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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PIN CUTTER 22" SIDECUTTER
Modern Surgical Instruments LLC
46-0626
In Commercial Distribution

  • 00810130203192 ()


  • Wire holding/twisting pliers
In-Situ Bypass Hooks, Angled, No Ball Tip, Titanium, Tip, 2mm, 7-1/2"
Modern Surgical Instruments LLC
71-1067
In Commercial Distribution

  • 00810130203178 ()


  • Soft-tissue surgical hook, reusable
Locking Pliers 9 1/2" Lrg, End/Side Connect for 700gr Slaphammer
Modern Surgical Instruments LLC
81.7158
In Commercial Distribution

  • 00810130201990 ()


  • Wire holding/twisting pliers
Locking Pliers 8" Med, End Side Connect for 400gr Slaphammer
Modern Surgical Instruments LLC
81.7156
In Commercial Distribution

  • 00810130201907 ()


  • Wire holding/twisting pliers
Kelly Blade 2" x 7"
Modern Surgical Instruments LLC
62-5120
In Commercial Distribution

  • 00810130201891 ()


  • Surgical retractor/retraction system blade, reusable
LAMBOTTE RACK FOR 9"OSTEOTOMES
Modern Surgical Instruments LLC
98-0190
In Commercial Distribution

  • 00810130201877 ()


  • Sterilization stringer
SL Narrow Muscle Blade 35mm Short Teeth, Anodised Dark Blue
Modern Surgical Instruments LLC
18-5535
In Commercial Distribution

  • 00810130201075 ()


  • Surgical retractor/retraction system blade, reusable
SL Narrow Tissue Blade 60mm /blunt Anodised Dark Gold
Modern Surgical Instruments LLC
18-5460
In Commercial Distribution

  • 00810130201068 ()


  • Surgical retractor/retraction system blade, reusable
SL Narrow Tissue Blade 55mm Blunt Anodised Black
Modern Surgical Instruments LLC
18-5455
In Commercial Distribution

  • 00810130201051 ()


  • Surgical retractor/retraction system blade, reusable
SL Narrow Tissue Blade 50mm Blunt Anodised Dark Violet
Modern Surgical Instruments LLC
18-5450
In Commercial Distribution

  • 00810130201044 ()


  • Surgical retractor/retraction system blade, reusable
SL Narrow Tissue Blade 45mm Blunt Anodised Olive Green
Modern Surgical Instruments LLC
18-5445
In Commercial Distribution

  • 00810130201037 ()


  • Surgical retractor/retraction system blade, reusable
SL Narrow Tissue Blade Blunt 40mm Anodised Dark Red
Modern Surgical Instruments LLC
18-5440
In Commercial Distribution

  • 00810130201020 ()


  • Surgical retractor/retraction system blade, reusable
SL Narrow Tissue Blade Blunt 35mm Anodised Dark Blue
Modern Surgical Instruments LLC
18-5435
In Commercial Distribution

  • 00810130201013 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 65mm Long Teeth Anodised Titanium
Modern Surgical Instruments LLC
18-5365
In Commercial Distribution

  • 00810130201006 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 60mm Long Teeth Anodised Dark Gold
Modern Surgical Instruments LLC
18-5360
In Commercial Distribution

  • 00810130200993 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 55mm Long Teeth Anodised Black
Modern Surgical Instruments LLC
18-5355
In Commercial Distribution

  • 00810130200986 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 50mm Long Teeth Anodised Dark Violet
Modern Surgical Instruments LLC
18-5350
In Commercial Distribution

  • 00810130200979 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 45mm Long Teeth Anodised Olive Green
Modern Surgical Instruments LLC
18-5345
In Commercial Distribution

  • 00810130200962 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 40mm Long Teeth Anodised Dark Red
Modern Surgical Instruments LLC
18-5340
In Commercial Distribution

  • 00810130200955 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 35mm Long Teeth Anodised Dark Blue
Modern Surgical Instruments LLC
18-5335
In Commercial Distribution

  • 00810130200948 ()


  • Surgical retractor/retraction system blade, reusable
SL Medial Muscle Blade 30mm Long Teeth Anodised Natural
Modern Surgical Instruments LLC
18-5330
In Commercial Distribution

  • 00810130200931 ()


  • Surgical retractor/retraction system blade, reusable
SL Lateral Muscle Blade 65mm Anodised Titanium
Modern Surgical Instruments LLC
18-5265
In Commercial Distribution

  • 00810130200924 ()


  • Surgical retractor/retraction system blade, reusable
INSTRUMENT STAND/INCLUDES 4 3.5MM SCREWS
INTERNATIONAL SURGICAL PRODUCTS INC
STR-STAND3.5
In Commercial Distribution

  • 00810129330458 ()


  • Sterilization stringer
WEINSTEIN RACK STRINGER 8" LONG 2.75" WIDE CENTER TO CENTER
INTERNATIONAL SURGICAL PRODUCTS INC
WSR-8
In Commercial Distribution

  • 00810129330441 ()


  • Sterilization stringer
WEINSTEIN RACK STRINGER 6" LONG 2.75" WIDE CENTER TO CENTER
INTERNATIONAL SURGICAL PRODUCTS INC
WSR-6
In Commercial Distribution

  • 00810129330434 ()


  • Sterilization stringer
Instrument: Drill and Screw Guide Holding Screw. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000T-SGHS
In Commercial Distribution

  • 00810135961431 ()


  • General internal orthopaedic fixation system implantation kit
EARP DISC RAKE The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DR
In Commercial Distribution

  • 00810135961042 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X14 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-1214
In Commercial Distribution

  • 00810135960908 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X12 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-1212
In Commercial Distribution

  • 00810135960892 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 12 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X14 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0614
In Commercial Distribution

  • 00810135960885 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
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